This is an open parallel design randomized trial of amiodarone plus a beta blocker vs a beta blocker alone vs sotalol for the prevention of ICD shocks in patients receiving an ICD for spontaneous or inducible ventricular tachycardia or...
Date First Received: November 22, 2005
Last Updated: July 26, 2006
Verified by: Connolly, Stuart, M.D., November 2005
Clinical Trial Phase: Phase 4 | Start Date: January 2001
Overall Status: Completed
Estimated Enrollment: 400
Brief Summary
Condition Keyword(s):
Intervention(s):
This is an open parallel design randomized trial of amiodarone plus a beta blocker vs a beta blocker alone vs sotalol for the prevention of ICD shocks in patients receiving an ICD for spontaneous or inducible ventricular tachycardia or fibrillation
Study Type: Interventional
Study Design: Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Intervention(s) in this Clinical Trial
- Drug: amiodarone beta blocker sotalol
Outcome Measures for this Clinical Trial
Primary Measures
- ICD shock for any cause
Criteria for Participation in this Clinical Trial
- Inclusion Criteria: spontaneous or inducible ventricular tachycardia or fibrillation -
Exclusion Criteria:
-
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Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 18 Years
Maximum Age for this Clinical Trial: N/A
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Sponsor Information
Lead Sponsor: Connolly, Stuart, M.D.
Overall Clinical Trial Officials and Contacts
Stuart Connolly Principal Investigator Hamilton Health Sciences
Related Publications
Citations Reporting Results
Connolly SJ, Dorian P, Roberts RS, Gent M, Bailin S, Fain ES, Thorpe K, Champagne J, Talajic M, Coutu B, Gronefeld GC, Hohnloser SH; Optimal Pharmacological Therapy in Cardioverter Defibrillator Patients (OPTIC) Investigators. Comparison of beta-blockers, amiodarone plus beta-blockers, or sotalol for prevention of shocks from implantable cardioverter defibrillators: the OPTIC Study: a randomized trial. JAMA. 2006 Jan 11;295(2):165-71.
Hohnloser SH, Dorian P, Roberts R, Gent M, Israel CW, Fain E, Champagne J, Connolly SJ. Effect of amiodarone and sotalol on ventricular defibrillation threshold: the optimal pharmacological therapy in cardioverter defibrillator patients (OPTIC) trial. Circulation. 2006 Jul 11;114(2):104-9. Epub 2006 Jul 3.
Additional Information
Information obtained from ClinicalTrials.gov on October 10, 2008
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00257959
Study ID Number: 1
ClinicalTrials.gov Identifier: NCT00257959
Health Authority: Canada: Ethics Review Committee
Clinical Trials Authorship and Review
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